Resting-state Functional Connectivity Changes During Migraine Treatment

Migraine Disorders Clinical Trial

Official title:

Resting-state Functional Connectivity Changes During Migraine Treatment: a Structural and Functional MRI Follow-up Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03484871
• Other study ID #: 2016-04-028
• Status: Withdrawn
• Start date: May 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether reduced frequency of migraine attacks are associated with signal alternation and connectivity of cerebral cortex.

Description:

Patients with migraine show reduced cortical thickness in regions subserving pain processing, and it is related to increasing headache frequency. In the past, only one study has shown a reversibility consequence of chronic nociceptive transmission, which normalizes when the pain is adequately treated. However, little is known whether these changes predispose to migraine or represent the effect of repeated migraine attacks. Our region of interest is reduced frequency of migraine attacks are associated with reversibility of signal alternation and functional connectivity of cerebral cortex.

In 30 migraineurs with 8-14days with headache per months who already performed brain magnetic resonance imaging will be recruited. Treatment medications such as frovatriptan and topiramate will be used for 6 months. After 6 months, follow-up brain magnetic resonance imaging will be performed.

The primary outcome is the longitudinal changes in functional connectivity in pain-processing/modulating brain regions. The secondary outcome is following: 1)longitudinal changes in structural and morphological alterations in brain regions of pain processing; 2)structural, morphological, and functional correlates of treatment response; 3)changes in monthly migraine days, migraine frequecies, headache days, and headache frequencies after treatment; 4)responses to acute migraine treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Premenopausal Women

• Aged 18-50

• Drug-naïve high frequency episodic migraineurs (8-14 attacks/m)

• Performed a baseline interictal brain MRI

Exclusion Criteria:

• Medication overuse

• Chronic pain other than migraine

• On treatment of major depression, bipolar, schizophrenia, or BDI>25

Related Conditions & MeSH terms

• Migraine Disorders

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional MRI imaging changes	temporal changes in BOLD correlations in the regions of most significant correlation with periaqueductal grey; temporal changes in BOLD correlations in the regions of most significant correlation with anterior cingulate cortex; temporal changes in default mode network	6 month
Secondary	structural MRI imaging changes	changes in cortical thickness of anterior cingulate, amygdala, periquiductal grey, and sensorimotor cortex	6 months
Secondary	Functional and structural correlates of treatment response	>50% reduction of monthly headache days	6 months
Secondary	correlation of functional MRI changes with changes in clinical parameters	changes in monthly headache days	6 months
Secondary	responses to acute migraine treatment	the Migraine Assessment of Current Therapy (Migraine-ACT) = 4	6 months after the first visit